Initial Importer and ISO 13485 (MDSAP) - Will the US company be included?

#1
If a parent company has a branch in the US who acts as the initial importer, is the parent or head office required to do an internal audit of the US distributor/initial importer? Note: the parent company has full control of the child initial importer. For the MDSAP audit of the head office covering both US and Canada requirements, will the US company be included in the MDSAP scope or will there be questions regarding this entity? Thank you.
 

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